MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number SXR07100R

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems Numbness (2415); Restenosis (4576)

Event Date 06/21/2021

Event Type  Injury  

Event Description

The user facility reported that after the initial procedure was performed using the misago device involved, the patient returned on (b)(6) 2021, with numbness and a cold leg.A reintervention identified restenosis at the site.There was also a supera used in the same lesion, number one.The artery of the lower extremity was not previously treated.The left limb was diseased.The location was at the superficial femoral artery (sfa) popliteal.The reference vessel diameter was approximately 6 millimeters.The lesion treatment was pre-dilation.The site of access/puncture and approach was at the radial artery retrograde.The patient was in stable condition.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.Additional information was received on 28 feb 2022: the initial procedure was performed on (b)(6) 2020.The procedure was a radial to peripheral runoff and intervention.Additional information was received on 04 mar 2022: the initial procedure was successful.There was 10 percent or less stenosis in each lesion.The reintervention performed was a covered stent to iliac (where the misago was placed).The supera used in lesion number one was placed in the distal sfa/popliteal.The vessel placement of the misago was stent iliac (off-label).Restenosis in the iliac was 80 percent.After reintervention/stenting, it was reduced to 10 percent.There was also restenosis of 10-30 percent in the supera stent.Left tibioperoneal (tp) trunk was also re-stenosed at 80 percent.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 13861632
• MDR Text Key: 287687186
• Report Number: 2243441-2022-00002
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727626
• UDI-Public: 04987350727626
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: SXR07100R
• Device Lot Number: 191227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2022
• Distributor Facility Aware Date: 02/25/2022
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANGIO JET ULTRA SPIROFLEX THROMBECTOMY SET; ARMADA; CHOCOLATE; CXI SUPPORT CATHETER; EVERCROSS; GLIDEWIRE STIFF SHAFT FLEXIBLE ANGLED; INDIGO REFERFUSION ASPIRATION CATHETER; NAVICROSS SUPPORT GUIDING CATHETER ANGLED; R2P CROSSTELLA; SPARTACORE; SUPERA 5 X 120; VERSACORE
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White